Approval for labeling changes to the package insert and patient brochure to include two additional potential adverse effects, pseudotumours and avascular lymphocyte dominated vasculitis associated lesions (alval) as well as an additional precaution that the subject device has not been tested in the magnetic resonance (mr) environment.
| Device | CORMET HIP RESURFACING SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | CORIN U.S.A. |
| Date Received | 2009-11-02 |
| Decision Date | 2009-12-03 |
| PMA | P050016 |
| Supplement | S005 |
| Product Code | NXT |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CORIN U.S.A. 12750 Citrus Park Lane suite 120 tampa, FL 33607 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050016 | | Original Filing |
| S012 |
2019-01-25 |
Normal 180 Day Track No User Fee |
| S011 |
2016-07-06 |
Normal 180 Day Track No User Fee |
| S010 |
2013-12-13 |
Real-time Process |
| S009 |
2012-02-14 |
Real-time Process |
| S008 |
2011-10-11 |
30-day Notice |
| S007 |
2010-11-19 |
Real-time Process |
| S006 |
2009-11-02 |
Real-time Process |
| S005 |
2009-11-02 |
Special (immediate Track) |
| S004 |
2008-09-29 |
Normal 180 Day Track No User Fee |
| S003 |
2008-05-16 |
Real-time Process |
| S002 |
2007-09-04 |
Real-time Process |
| S001 |
2007-07-16 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices